Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05414422 | A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD | PHASE2 | COMPLETED | 102 | — | — | Feb 1, 2022 | Nov 10, 2022 | Jun 4, 2024 | 21 | United States, Germany +1 |
Change from baseline to 24 hours after the start of infusion in the Montgomery Asberg Depression Rating Scale (MADRS). The overall score ranges from 0 to 60. Higher scores indicates more severe depression.
| Arm | Type | Description |
|---|---|---|
| PCN-101 30 mg | EXPERIMENTAL | PCN-101 30 mg |
| PCN-101 60 mg | EXPERIMENTAL | PCN-101 60 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| PCN-101 | DRUG | Concentrate for solution for infusion |
| Placebo | DRUG | Concentrate for solution for infusion |
Inclusion Criteria: * Capable of giving and give signed informed consent * Weigh \>= 50 kg and have a body mass index \>= 18 and \<= 35 * Diagnosis of recurrent major depressive disorder (MDD) without psychotic features per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V...